On March 1st of this year I wrote to you, urging that you “launch an investigation into criminal charges against Schering-Plough based on the possibility that the company knowingly shipped millions of the 59 million units of albuterol-containing asthma drug eventually recalled, between the time the company became aware of the seriously flawed manufacturing processes and the time the March, 2000 recall was finally accomplished.” The company had explained that the basis for the recall was “the remote possibility that an aerosol container may not contain active drug."

The failure to be able to treat and stop an acute asthmatic attack, because there is no asthma drug in the inhaler upon which the patient relies, is obviously a life-threatening situation. We therefore subsequently have analyzed adverse reaction report data obtained from the FDA and found that there was a pattern of deaths in users of Schering-Plough albuterol products which had occurred around the time of the two (9/99 and 3/00) recalls. Thus, this new information along with other findings discussed below, significantly adds to the compelling case for criminal prosecution of Schering-Plough.

As can be seen on the chart below, there were no deaths reported to the FDA to have occurred in users of Proventil or Warrick’s albuterol (generic version also manufactured by Schering-Plough) during the first three quarters of 1998. However, starting with a death that occurred in the fourth quarter of 1998 and continuing through the second quarter of 2000, there were a total of 17 deaths for which the Schering-Plough albuterol was listed as the “primary suspect” and in which there is a date of death. During the last two quarters of 2000, the last period for which we have been able to obtain data, there have been no subsequent deaths reported to have occurred in users of these products. For an additional seven deaths in people using these asthma inhalers, there was no exact date of death given and the cases were reported to the company between March 30th and August 9, 2000.

This pattern of deaths, with none occurring before or after the interval during which the defective albuterol inhalers were shipped for use is known as a point source epidemic and strongly implicates these products as causes of the deaths.

Of the seventeen patients with known dates of death, ten of them were using, or attempting to use, inhalers from the lots which were eventually recalled, including two from the lot recalled in September, 1999 and eight from the lots recalled in March, 2000 according to the FDA documents. For the other seven patients, lot numbers were not listed in the FDA data we received. In information also included with the FDA adverse reaction reports, for five of the 17 patients who died there were comments indicating that the patients had not gotten relief from their asthmatic attacks from the Schering-Plough inhalers. The remarks included those of a 21-year-old, shortly before his death, who “complained on several occasions that his albuterol inhaler did not seem to treat his asthma attacks as usual”. A ten-year-old boy who had an asthmatic attack “reached for his inhaler and obtained no relief” and died shortly thereafter. Both of these people were using inhalers from the recalled lots. Of those who died whose ages were known, six were under the age of 30 including three who were less than 20 (10, 12, and 16).

Although many of these deaths occurred before the first recall and most of the rest before the second recall, most were not reported to the company, according to the company’s data, until after the second recall. One likely explanation is that it is counterintuitive for patients, their families, or physicians to believe that an asthma inhaler could be so shoddily manufactured as to fail to contain the asthma drug. Therefore, until the widespread publicity following the second recall, the link between the deaths and the defective inhalers was probably not suspected by many people. It was, in fact, after the second recall, on March 29, 2000, that Schering-Plough advised that "Proventil and Warrick brand albuterol patients using a canister without active drug will not obtain their usual relief from asthma symptoms." The company press release stated that “an inhaler that does not contain active drug is a serious matter that merits immediate attention.”

However, at least one death case was known to the company on January 4, 2000, prior to the second (March 29, 2000) recall and this death may well have helped to precipitate the February to April, 2000 outside audit by the AAC Consulting Group, during which the March 29th recall of 59 million units of albuterol aerosol inhalers was finally done.

According to FDA documents, a woman of unknown age who had a previous history of “well-controlled asthma” who was using one of the inhalers from a lot eventually recalled in March, 2000, died in September 1999 and the company was notified on January 4, 2000. Unfortunately, it was almost three months after Schering-Plough learned about her death that the March 29th recall was belatedly undertaken. During these first three months of 2000, while Schering-Plough was aware of her death but did not recall the inhalers, another five deaths occurred in people using inhalers that were recalled on March 29, 2000.

Aside from delaying the second recall almost three months after learning of a death in a woman using the eventually-recalled product, Schering-Plough was reckless in not recalling all of the eventually recalled lots at the time they recalled the one lot, 9-BBS-525, in September, 1999. According to the company’s press release of September 9, 1999, announcing that first recall of 190, 000 asthma inhalers, it was precipitated after “one patient returned an inhaler that did not contain drug substance”. It is of great importance that when the massive, 59 million unit recall of March 29, 2000 was finally ordered, lots which, according to their lot number and expiration dates, were manufactured both before and after the 9-BBS-525 lot were ultimately recalled. Thus, Schering-Plough made a financially conservative but public health reckless decision in September, 1999 that, despite a long history of systemic problems involving the manufacture of albuterol inhalers, only the lot from which the patient was unable to relieve his/her asthma attack would be recalled. At the time of the second (March, 2000) recall, the company belatedly admitted that “the [March] recall relates to an aerosol manufacturing problem that had been previously identified in October 1999.” Although all lots of the massive March 2000 recall were said to have been manufactured before September 30, 1999, it is likely, if not certain, that the company shipped many of these lots into channels of commerce after that date.

In our initial letter, the request for a criminal investigation was based on the long standing pattern of dangerously sloppy manufacturing, including albuterol inhalers, at Schering-Plough’s New Jersey plant, repeatedly documented in FDA inspections, FDA warning letters to the company and in the company’s private audit by AAC Consulting Group, during which the March, 2000 recall finally occurred (see our letter to you of March 1, 2001). Now, there is additional evidence that the company not only failed to recall millions of defective asthma inhalers for three months after learning on January 4, 2000 of a death in a woman using one of these inhalers, but that there were many deaths in people which would have been avoided if there been an earlier, September, 1999 recall of the 59 million units.

Based on this new information concerning the deaths, there is even more reason for criminally prosecuting Schering-Plough for introducing these defective products into the marketplace and failing to recall them much earlier. If you have any questions about this serious problem, please call and I will meet with those involved.

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